Final Record of Decisions November 8, 2018 Meeting: Canada’s Medical Technology Companies (MEDEC)
Health Canada - Health Products and Food Branch (HPFB)
Bilateral Meeting Program
1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario
November 8, 2018
(1:00 p.m. to 3:40 p.m.)
Diana Johnson, Vice-President, Regulatory Affairs, MEDEC, Co-chair
La-Toya Salmon, Baxter
Alan Coley, Coley Consulting
Greg Leblanc, Cook Medical
Charles Tam, Edwards Lifesciences
Stefan Feix, GE Healthcare
Young Kim, Johnson & Johnson Medical
Sally Prawdzik, Johnson & Johnson Medical
Dinar Suleman, LifeScan
Kelly Makimoto, SciCan
Monica Magidin, Siemens Healthcare
Health Canada Participants
John Patrick Stewart, Therapeutic Products Directorate (TPD), Co-Chair
David Boudreau, Medical Devices Bureau (MDB), TPD
Melanie Adams, Marketed Health Products Directorate (MHPD)
Rebecca Bose, MHPD
Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
Sarah Chandler, MDB, TPD
Maria Carballo, MDB, TPD
Mandy Collier, OPPRS, TPD
Sindy Fernando, Resource Management and Operations Directorate (RMOD)
Colin Foster, MDB, TPD
Émile Geoffroy, OPPRS, TPD
Frédéric Hamelin, MDB, TPD
John Helmkay, MDB, TPD
Alexandra Hughes, RMOD
Dayna Kearns, Regulatory, Operations and Enforcement Branch (RORB)
Amanda Jones, MDB, TPD
Marc Lamoureux, MDB, TPD
Joseph Mikhael, RMOD
Leanne Moore, MHPD
Matthew Ryan, RORB (by teleconference)
Kathy Soltys, MHPD
Colleen Turpin, MHPD
Donna Watt, OPPRS, TPD
Daniel Yoon, BPSIP, TPD
- Welcome and Introductions
John Patrick Stewart, Director General of the Therapeutic Products Directorate (TPD), welcomed everyone and thanked MEDEC representatives for participating face-to-face. He indicated that TPD values these meetings and finds them to be informative. It continues to be an active time in TPD with a high number of key ministerial and branch priorities underway, including the Health Products and Food Branch’s initiative to improve the Regulatory Review of Drugs and Devices (R2D2). All 15 of the projects included within R2D2 have progressed. The Medical Devices Bureau’s (MDB’s) Digital Health Division has been established; the transition to the Medical Device Single Audit Program (MDSAP) is underway; and cost recovery proposals are anticipated to be in place in early 2019.
For TPD organizational changes, Celia Lourenco will be leaving to become Director General of the Biologics and Genetic Therapies Directorate (BGTD) and Marilena Bassi, former Director of the Bureau of Policy, Science and International Programs, will take on the role of Senior Executive Director.
Diana Johnson, MEDEC Co-chair, indicated that MEDEC members are excited to be engaged with Health Canada and are looking forward to the future. MEDEC has one organizational change: Linda Lindsay is stepping down as Chair of the Regulatory Affairs Committee (RAC) and Sally Prawdzik is the new Chair.
David Boudreau, Executive Director, MDB, indicated that this is a time of transformation. MDB appreciates receiving any suggestions to improve the regulatory system as it is interested in improving and adapting. MDB understands from comments from stakeholders that it is important to ensure that regulations adapt to technologies rather than adapting technologies to regulations. MDB appreciates MEDEC’s feedback on TPD initiatives so that it can move forward with the medical device sector.
Review of Agenda
There were no changes to the agenda.
Approval of Meeting Notes / Action Items of the May 24, 2018 Meeting
The minutes of the previous meeting on May 24, 2018 were approved. The action items from the previous meeting were completed.
Health Canada’s Approach to the Implementation of Table of Contents (ToC)
On August 21, 2018 Health Canada provided MEDEC with a notice detailing its approach to the implementation of the Table of Contents (ToC) format for Class III and IV premarket licence applications. MEDEC requested that the consultation with industry should also focus on content and not just format. Maria Carballo, Manager, In Vitro Diagnostic (IVD) Device Evaluation Division, Medical Devices Bureau addressed this item. MDB responded that MEDEC is welcome to provide any comments related to the ToC Guidance Document. MDB has received over 70 applications for the International Medical Device Regulators Forum (IMDRF) pilot guidance. Health Canada will be publishing a draft guidance where feedback will be collected over a one year period, after which a final guidance will be published. MEDEC requested information on what guidance manufacturers should follow when putting in their first IVD submission. MDB responded that the ToC Guidance Document contains everything that is required to create a ToC.
Status of Scientific Advisory Committee on Digital Health Technologies (SAC-DHT) and New Digital Health Division
MEDEC requested an update on the Digital Health Division that was established within MDB in March 2018 and also the new Scientific Advisory Committee on Digital Health Technologies (SAC-DHT). Marc Lamoureux, Manager, Digital Health Division, MDB and Daniel Yoon, Bureau of Policy, Science and International Programs, TPD addressed this item. The new Digital Health Division in MDB is responsible for reviewing, among other technologies, software as a medical device; diagnostic, therapeutic, and cosmetic radiation devices; and is undertaking newer digital health technology, such as cybersecurity, artificial intelligence and mobile apps. In addition to routine pre-market review of the technologies listed above, the Digital Health Division is undertaking new and novel initiatives in building expert review capacity, developing guidance, and engaging with stakeholders.
For the upcoming Scientific Advisory Committee on Digital Health Technologies (SAC-DHT), over 100 applicants responded to Health Canada’s June 8, 2018 call for nominations. Members were identified through consultation with a broad array of sources. The core panel membership consists of six highly qualified professionals in digital health and a patient group representative and the ad hoc panel was chosen based relevant experience in medical device cybersecurity. Security clearances and conflict of interest forms are now being filled out and approved. See SAC-DHT for the Terms of Reference, membership and meeting information.
The inaugural meeting of the SAC-DHT is scheduled for Friday November 23rd, 2018 and most of the agenda is related to medical device cybersecurity. MEDEC has been invited to provide a presentation and indicated that more time to develop the presentation would be beneficial in the future. MDB responded that Health Canada has received an overwhelming response from people wishing to be included on this Committee therefore scheduling has been a challenge. Although no formal decisions have been made, an “Artificial Intelligence” SAC-DHT meeting is tentatively planned to be held in 2019. Note that ad hoc members for that meeting have not yet been identified.
Regulatory Enrolment Process (REP)
Sarah Chandler, A/Associate Director, Medical Devices Bureau, TPD, Joseph Mikhael, Sindy Fernando, and Alexandra Hughes of the Resource Management and Operations Directorate (RMOD) presented this item. REP was first presented to MEDEC at the Fall 2017 bilateral meeting. RMOD is now seeking stakeholder participation in a pilot focused on Class III and IV new and amendment applications and all companies are encouraged to sign up. Note that participation in the pilot will be limited to applications being submitted in the Table of Content (ToC) format. See the Notice for the pilot.
On February 5, 2019, Health Canada published a notice with validation rules for regulatory transactions in “non-electronic Common Technical Document (eCTD) electronic only” format. These rules also apply to medical device licence applications. In order to provide good quality applications to the review bureau, please ensure applications are free of validation errors and warnings.
Alexandra Hughes, RMOD, presented a demonstration of the Common Electronic Submission Gateway (CESG). MEDEC requested information as to whether a separate web trader account is required for each manufacturer. RMOD responded that it is in the process of looking into that.
RMOD indicated that companies will only need to enroll their company once, and amend only when needed. The company ID is referenced in subsequent templates and detailed manufacturer information does not need to be repeated with each application. When the actual application is filed, the company will receive two e-mail acknowledgements, one from the United States Food and Drug Administration (US FDA) and the other from Health Canada. MDB indicated that so far, six companies have registered for the pilot. Using REP and the TOC format, companies can submit through the CESG what they typically would have sent via mail on CD. Companies are encouraged to ensure that they have enough time to create a CESG account. RMOD is willing to meet with MEDEC members or host a Webex in order to provide guidance for using the system.
Post Market Activity / Requirements Update and Progress
MEDEC requested an update to the Health Canada activities related to post market surveillance and post market reporting. Matthew Ryan, Manager, Regulatory Operations and Regions Branch (RORB), addressed this item. The Treasury Board of Canada Secretariat is currently conducting a targeted regulatory review which will identify bottlenecks and other areas of regulation that can be improved. The reviews will also explore ways to make regulations more agile, transparent and responsive so that businesses can grow, resulting in benefits for all Canadians. The recall amendments are currently listed on Health Canada’s Forward Regulatory Plan and RORB is anticipating that they will be pre-published in Canada Gazette I for a 75 day consultation period in Spring 2019. RORB indicated that there would be an opportunity for pre-consultation during the Canada Gazette Part I process.
MEDEC requested an update to changes that were previously announced regarding plans for medical device manufacturers to provide annual reporting regarding device safety and performance. Rebecca Bose, Senior Policy Analyst, Marketed Health Products Directorate (MHPD), addressed this item. The proposed post-market surveillance regulations are projected to appear in Canada Gazette Part I in the late spring of 2019. MHPD anticipates that the draft guidance will be published at the same time on the Health Canada website so that stakeholders can see how the provisions would be applied. The regulations include some proposed provisions related to Vanessa’s Law and some post-market surveillance provisions (including annual summary reports). An information session for stakeholders will be held via Webex on the afternoon of November 22, 2018. A cost-benefit survey on the regulations will also be sent out to stakeholders. MEDEC indicated that it had received the invitation to the information session and has circulated it to members.
Mandatory Reporting of Serious Adverse Drug Reactions (ADRs) and Medical Device Incidents (MDIs) by Hospitals
Leanne Moore, Manager, and Colleen Turpin, Project Lead, Marketed Health Products Directorate (MHPD) presented this item. The proposed mandatory reporting regulations would amend the Food and Drug Regulations and the Medical Devices Regulations to require hospitals to provide reports of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) directly to Health Canada. The draft regulations were published in Canada Gazette, Part I, and stakeholders had until August 29, 2018 to provide their feedback on the proposal. After analyzing the feedback, Health Canada will consider if any changes are necessary before publishing the final regulations on Canada Gazette, Part II.
The goal is to make sure that serious ADRs and MDIs are reported to Health Canada so that there is enough information to detect safety problems. Improving Health Canada’s knowledge about product safety will help Canadians and their health care providers to make better, more informed decisions about their medical treatment and support overall patient safety. Currently, for ADRs, all domestic adverse reaction reports are published to the Health Canada website via the Canada Vigilance Adverse Reaction Online Database. For MDIs, Health Canada is currently exploring the possibility of releasing adverse event reports in line with the methods used for ADR reports. Database improvements are being explored to improve the access to all domestic ADR/MDI reports. MEDEC asked if there would be an opportunity for a lay user to understand that an incident was investigated. MHPD responded that the external database does not comment on causality (eg. what was related). MEDEC indicated that manufacturers use that to determine if they need to report. The association expressed concern that adding multiple reporting sources such as hospitals could result in multiple reports of the same incident. MEDEC indicated that this could be a good opportunity to create a causality column.
MEDEC indicated that the information that manufacturers currently receive from the Sentinel report is not enough for them to do a proper review. MHPD is in the process of developing a health care professional form for reporting and will be asking for MEDEC’s feedback. MHPD will be in touch with MEDEC once they are ready to receive comments on the Mandatory Reporting for Hospital Forms.
MHPD indicated that if the product and manufacturer can be identified from the company ID and there is a contact e-mail address in the database, then MHPD may be able to send reports directly to the manufacturer. MEDEC responded that the longer it takes to get the report information from the hospital or Health Canada, the longer it takes to find the device in question. If the device is disposable, it may no longer be available for investigation.
MEDEC indicated that it is good to see a joint venture concept and that outreach and education is excellent. It is important for clinicians to see the value in reporting adverse events to Health Canada.
Global Medical Device Nomenclature (GDMN) - Medical Device Application Forms
MEDEC requested an update on the transition from Health Canada’s current medical device categorization method to the Global Medical Device Nomenclature (GMDN). Colin Foster, A/Manager, Device Licensing Services Division, Medical Devices Bureau, TPD addressed this item. As of September 24th, 2018, out of the 3,655 recipients of Health Canada’s request for GMDN codes, responses were received from 1,667 manufacturers (45.6%) and 294 manufacturers (8%) had notified Health Canada of their inability to provide codes. For the remaining 41 manufacturers who hold more than 100 licences, the final deadline to submit codes is November 20th, 2018.
GMDN codes are provided to Health Canada on a voluntary basis. Although participation is encouraged and appreciated, as this will allow Health Canada to update over three hundred thousand device IDs more efficiently, Health Canada intends to assign codes for all devices for which a response was not received. Health Canada may request additional assistance from manufacturers in the future. Health Canada is considering a pilot project where the review divisions will validate code assessment.
Medical Device Licence Amendment Fax-back Process Improvement
During the May 2018 TPD/MEDEC Bilateral Meeting, Health Canada shared its performance Improvement Plan and intention to improve the faxback process and MEDEC requested an update. Colin Foster, A/Manager, Device Licensing Services Division, Medical Devices Bureau, TPD addressed this item. In July 2017, Health Canada e-mailed all stakeholders to inform them of rejection criteria that would result in the rejection of Fax-Back Applications. MEDEC indicated that it had circulated this notice to members. Health Canada is working on new application forms which are designed to prevent applicants from making common mistakes on fax-backs that result in deficiencies and rejections (e.g. failure to complete sections). No additional rejection criteria will be developed or implemented until MDB can evaluate the impact that the new application forms will have on application deficiencies.
Medical Device Single Audit Program (MDSAP) Update and Progress
MEDEC requested a progress report on the MDSAP program and next steps. Frédéric Hamelin, Manager, Quality Systems Section, Medical Devices Bureau (MDB), TPD addressed this item. The transition to MDSAP is well underway. As of the end of May, 2018, 50% of manufacturers had completed or initiated their transition to MDSAP. MDB updated the MDSAP FAQ document to provide clarification on exemptions for manufacturers unable to schedule an audit prior to December 31, 2018. MEDEC indicated that it has had webinars on MDSAP and the Questions and Answers are published on its website. Health Canada indicated that it is not interested in suspending the licences of any manufacturer that is willing to make the transition.
The Auditing Organization (AO) cannot issue the certificate while there are still outstanding questions on the report. MEDEC indicated that it is taking four to five months for a certificate to be issued. Health Canada responded that there are a lot of things that are contributing to this delay. Also, there is a lot of back and forth for the closure of non-conformities. Health Canada expressed concern that certain companies may have not yet initiated contact with their AO.
MDB is monitoring potential issues related to market exit as a result of MDSAP. It is unfortunate when manufacturers decide to leave the Canadian market. It was anticipated that 193 manufacturers and 1,750 licenses would be lost and this is close to what has actually happened. MEDEC indicated that the auditing organizations are not being consistent and that companies are receiving questions that they feel could have been answered at Stage I. Also, companies cannot tell if they are receiving a small business discount. MDB indicated that there will be a MDSAP Forum in December 2018 in Washington, D.C. MDB added that the goal is to help everyone with the transition to MDSAP and the priority is to get packages in without too much variation so that there is no duplication. Health Canada is developing strategies and an update on MDSAP will be provided at the next bilateral meeting in Spring 2019.
Update from Investigational Testing Authorization (ITA) Consultation
MEDEC indicated that it is pleased that Health Canada has initiated steps to update the Guidance Document Applications for Medical Device Investigational Testing Authorizations and requested an update. David Boudreau, Executive Director, MDB, TPD and Amanda Jones, Senior Scientific Evaluator, MDB, TPD addressed this item. Following broad consultation with stakeholders and careful analysis of the feedback and recommendations that were received, an updated version of the ITA Guidance Document was drafted and published online on October 1, 2018. This latest version of the guidance document offers additional clarity and describes when new ITA and amendment applications are required, and identifies policy and process improvements that provide more flexible approaches for applicants. Taken together the changes are expected to reduce regulatory burden and facilitate market access to new and innovative medical devices for Canadian patients without compromising safety.
MDB indicated that it is looking for more agile ways to update Guidance Documents. MEDEC noted that Health Canada has taken a lot of steps to reduce burden scenarios, in particular, Research Ethics Board (REB) and pulse sequence. This will allow top researchers to compete in Canada. MEDEC noted that there are a few areas that stand out as a grey zone in terms of notification of changes. The association indicated that labelling can be a challenge when the product is very small (eg. a scalpel). Health Canada responded that the product just needs to be labelled at some level so that the investigator knows it is an investigational product. MEDEC indicated that another challenge is that the Guidance uses the term Instructions for Use (IFU), rather than labelling. MDB responded that it has noted that issue and will ensure that it is addressed in the update.
MEDEC suggested that the studies for medical devices be laid out in the same way as the drug studies. Health Canada indicated that it is already taking that into consideration. Health Canada reminded MEDEC that comments can be provided at any time at Medical Devices Investigational Testing Questionnaire. MEDEC can also send comments to the general email inbox at: email@example.com
Medical Devices Bureau (MDB), TPD/Marketed Health Products Directorate (MHPD)/ Regulatory Operations and Regions Branch (RORB) Performance
John Helmkay, Senior Business Process Officer, MDB, TPD, Kathy Soltys, Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate (MHPD), Leanne Moore, MHPD, Matthew Ryan, Regulatory Operations and Regions Branch (RORB), provided a presentation to MEDEC and encouraged a discussion related to performance reporting. The Medical Devices Program Performance Report for the second quarter of fiscal year 2018-19 included information on licences and authorizations, screening time against the 15 day target, volume of screening deficiencies, time to first decision, volume of additional information requests, time for second decisions, and market authorization time. Statistics for the Regulatory Operations and Regions Branch and the Marketed Health Products Directorate were also provided.
MEDEC requested information on how it can avoid screening deficiencies. MDB responded that it has received many applications that are incomplete and that MEDEC members should provide as much information as they can. MDB indicated that it is working on three Guidance Documents that should help provide guidance to manufacturers: Software as Medical Device (SaMD), cybersecurity and 3D printing. The Bureau is also working on optimizing and bringing more consistency into reviews. MEDEC indicated that it would be interested in collaboration with Health Canada to prepare a template for the Summaries section, so there is more guidance available to industry regarding Health Canada expectation in this section.
Action: MDB to provide a Webinar on improving submission quality.
For adverse event codes from the International Medical Device Regulators Forum (IMDRF), MHPD indicated that Annexes A through D have already been adopted and Annexes up to F will be adopted on October 12, 2018. A meeting will be held in Singapore to adopt the Annexes. Annex G describes components. MHPD recognizes that industry has identified certain needs to support manufacturer coding. MHPD might adopt a similar approach as the drugs side and work with a few at a time.
The percentage of workload in backlog is below 10% for all fee lines. MDB is preparing for January 2019 with a goal of 100% decisions on time goal in the first quarter of the year and would appreciate any feedback from MEDEC so it can anticipate workload for Spring 2019. MEDEC indicated that only a few of its members are in the small business category.
Action: The quarterly review will be published the week of November 19, 2018. MDB will send MEDEC the web link.
Post-market Surveillance Regulations - Kathy Soltys, MHPD re-iterated the invitation extended to MEDEC in Item #7 of this agenda to attend an information session for stakeholders that will be held via Webex on November 22, 2018.
Cost Recovery - Once Cost Recovery has been finalized, stakeholders will be notified as per the usual process.
Labelling - MEDEC requested information about the promotional issue and the labelling concerns that it submitted. MDB responded that it is considering a broader outreach to health care professionals that might be impacted for that labelling. It is anticipated that an update on the topic will be provided to MEDEC in early 2019. MEDEC noted that Section 27 of the Medical Device Regulations states that if a product is not licensed, it cannot be promoted in catalogues. The association added that when it is a global label it is hard to go back to manufacturers to have a label put in, especially when it is not a safety issue. MDB indicated that it is moving away from the promotional aspect and is looking more at when information is presented in a misleading manner.
MedTech Conference - MEDEC indicated that they are preparing for the next MedTech conference at the end of June 2019 and asked if it would be possible for MDB to provide Webinars before the conference takes place. MEDEC should send any suggestions for webinars to MDB. MEDEC asked if they could reuse the content from the Regulatory Affairs Professionals Society (RAPS) meeting and request the Health Canada perspective on the information. MDB indicated that it is receptive to the idea.
Antimicrobial Resistance (AMR) - John Patrick Stewart, TPD, presented this item. In support of the Federal Action Plan on Antimicrobial Resistance and Use in Canada, Health Canada is committed to facilitating regulatory approval for safe, effective, and high quality innovative products that help address the issue of AMR. The Pathogens of Interest list is expected to be published the week of November 19, 2018. Health Canada is interested in promoting point of care diagnostics for AMR and device companies are encouraged to consider how to contribute to helping the situation.
John Patrick Stewart, TPD, and Diana Johnson, MEDEC, thanked meeting participants.
The meeting was adjourned at 3:40 p.m.
Original signed by:
John Patrick Stewart
Therapeutic Products Directorate
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